EndometriosisAdodreamNCT05153512
ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
An observational study of Endometriosis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
To date, no MRI study has been published describing the prevalence of endometriosis in adolescent girls, not even in those with significant dysmenorrhea and therefore more particularly at risk. Likewise, there are no precise data on the type of superficial or early-onset deep endometriosis that appears in adolescence. Read more about this study
- Who is it for?
- Ages 12 to 20 years, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- MRI
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 350 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2019to 26 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- Women only
- Child, Adult
Study population: Women between 12 and 20 years-old and suffering from dysmenorrhea
Who may be able to join
- Patient aged between 12 and 20 years old.
- After menarche.
- Requiring pelvic MRI for exploration of dysmenorrhea (after or not ultrasound), in the case of patients with suspected endometriosis, or for any other reason (cyst, tumor, non-obstructive urogenital malformations), in the case of patients without symptoms clinic associated with endometriosis.
- Patient affiliated or beneficiary of a social security scheme.
- Patient and her legal representative, if applicable, having been informed and not opposing this research.
Who cannot join
- Patient whose pelvic MRI is performed as part of an exploration of obstructive uterine malformations.
- Patient claustrophobic, making it impossible to perform an MRI.
- Contraindication to MRI: pacemaker, ferromagnetic object incompatible with MRI.
- Pregnant, breastfeeding or parturient woman.
- Protected patient: Major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision; Hospitalized without consent.
Trial locations and contacts
1 site in 1 country.
Marie-Hélène Barba contact
France1 site, 1 recruiting
- Recruiting
BLOMET clinic
Paris, IDF, 75015
Marie Barba, +330664888704 ext. +330664888704, mh.barba@ecten.eu
Jean Francois OUDET, +33683346567 ext. +33683346567, jf.oudet@ecten.eu
About this study
Official title: ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging
To date, no MRI study has been published describing the prevalence of endometriosis in adolescent girls, not even in those with significant dysmenorrhea and therefore more particularly at risk. Likewise, there are no precise data on the type of superficial or early-onset deep endometriosis that appears in adolescence. The collection of these data would allow an earlier diagnosis, because it is better documented, of endometriosis. The lesions would then be treated earlier, avoiding their development and the problems of infertility related to this pathology. The aim of this sudy is to assess the prevalence of endometriosis and its phenotypic representation in the study population consulting for dysmenorrhea with suspected endometriosis.
- Conditions
- Endometriosis
- Being tested
- MRI
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
Pelvic MRI without injection of contrast product and WITHOUT rectal or vaginal opacification
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient with endometriosis detected on MRI
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start26 Sep 2019
- Primary completion26 Jun 2020
- Study completion26 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05153512
- Sponsor's protocol ID
- 2018-A01354-51
- Acronym
- Adodream
- Status last verified
- Dec 2021
- First submitted
- 25 Nov 2021
- Last updated
- 10 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Millischer AE, Santulli P, Da Costa S, Bordonne C, Cazaubon E, Marcellin L, Chapron C. Adolescent endometriosis: prevalence increases with age on magnetic resonance imaging scan. Fertil Steril. 2023 Apr;119(4):626-633. doi: 10.1016/j.fertnstert.2022.12.039. Epub 2022 Dec 31.
PubMed 36592649
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT05153512
- Acronym / sponsor ID
- Adodream / 2018-A01354-51
- Conditions
- Endometriosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 26 Dec 2021 (estimated)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To date, no MRI study has been published describing the prevalence of endometriosis in adolescent girls, not even in those with significant dysmenorrhea and therefore more particularly at risk. Likewise, there are no precise data on the type of superficial or early-onset deep endometriosis that appears in adolescence. The collection of these data would allow an earlier diagnosis, because it is better documented, of endometriosis. The lesions would then be treated earlier, avoiding their development and the problems of infertility related to this pathology. The aim of this sudy is to assess the prevalence of endometriosis and its phenotypic representation in the study population consulting for dysmenorrhea with suspected endometriosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 to 20 years
- Sex
- Female only
- Age groups
- Child, Adult
- Study population
- Women between 12 and 20 years-old and suffering from dysmenorrhea
Key inclusion criteria (5 listed)
- Patient aged between 12 and 20 years old.
- After menarche.
- Requiring pelvic MRI for exploration of dysmenorrhea (after or not ultrasound), in the case of patients with suspected endometriosis, or for any other reason (cyst, tumor, non-obstructive urogenital malformations), in the case of patients without symptoms clinic associated with endometriosis.
- Patient affiliated or beneficiary of a social security scheme.
- Patient and her legal representative, if applicable, having been informed and not opposing this research.
Key exclusion criteria (5 listed)
- Patient whose pelvic MRI is performed as part of an exploration of obstructive uterine malformations.
- Patient claustrophobic, making it impossible to perform an MRI.
- Contraindication to MRI: pacemaker, ferromagnetic object incompatible with MRI.
- Pregnant, breastfeeding or parturient woman.
- Protected patient: Major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision; Hospitalized without consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIPelvic MRI without injection of contrast product and WITHOUT rectal or vaginal opacification | Procedure or surgery | – |
Primary outcome
Number of patient with endometriosis detected on MRI
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2021.
- Derived from this study: PubMed 36592649Millischer AE, Santulli P, Da Costa S, Bordonne C, Cazaubon E, Marcellin L, Chapron C. Adolescent endometriosis: prevalence increases with age on magnetic resonance imaging scan. Fertil Steril. 2023 Apr;119(4):626-633. doi: 10.1016/j.fertnstert.2022.12.039. Epub 2022 Dec 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie-Hélène Barba contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-François Oudet (0683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient with endometriosis detected on MRI (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05153512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2021.